Two problems frequently encountered during the closure of surgical incisions of the abdomen are risk of injury to the bowel and the postoperative formation of adhesions to the abdominal wall.
Bowel injury leads to significant risk of infection, poor wound healing, hernia formation, and death. Bowel injury may be undetected at the time of surgery, leading to leakage of intestinal content into the abdominal cavity with resulting infection. If not diagnosed and treated promptly, this type of bowel injury carries a high risk of peritonitis, poor wound healing, hernia formation, and possible death. A mechanical barrier placed within the abdominal cavity prior to surgical closure of the abdominal wound reduces the risk of bowel injury during closure. Currently, surgeons occasionally utilize various barrier type devices during the closure of the abdomen to reduce the risk of bowel injury. These devices may be rigid such as a flat steel surgical retractor. Semi-rigid devices made of rubber or plastic are also utilized for this purpose, examples of which are shown in U.S. Pat. Nos. 4,964,417 and 4,747,393. These devices are not bioabsorbable and must be removed prior to completion of the surgical closure of the abdomen and therefore ultimately do not reduce the risk of postoperative adhesions. Surgical closure of the abdomen performed with the assistance of these currently available devices carries a significant risk of postoperative adhesion formation which may result in bowel obstruction.
Postoperative adhesions are the most frequent cause of small bowel obstruction, a common condition with significant morbidity and mortality, often requiring surgical intervention. The majority of these patients suffer obstruction due to intra-abdominal adhesions. These adhesions are the result of scar formation frequently associated with prior abdominal surgery. Bowel obstruction due to abdominal adhesions causes pain, vomiting, and may lead to gangrene of the bowel. Bowel obstruction due to adhesions frequently requires surgical treatment which may lead to a recurrent cycle of scar formation, obstruction, and surgery. A product which prevents the development of adhesions between the bowel and abdominal wall may be placed within the abdominal cavity prior to surgical closure of abdomen. Such a product may be a prosthesis made of silicone elastomer and/or polypropylene mesh fabric, such as disclosed in U.S. Pat. No. 5,593,441. Such a device however is not bioabsorbable. Currently, surgeons occasionally utilize various adhesion preventing materials during the closure of the abdomen to reduce the risk of postoperative adhesions. Products known to be effective in the prevention of adhesions include chemically modified sodium hyaluronate and carboxymethylcellulose, such as provided in SEPRAFILM® brand adhesion barrier manufactured by Genzyme Corporation, Cambridge, Mass. However, these materials are difficult to apply, being extremely friable, and having a tendency to stick to any surgical instrument once wetted after contacting tissue. Such a material also generally is provided as a thin layer or coating of material which is easily penetrated and therefore does not reduce the risk of injury to the bowel or other underlying tissue during closure of a surgical incision.
There currently exists no device which addresses all of the aforementioned problems during the closure of a surgical incision, such as in abdominal surgery. Efforts to employ current adhesion-preventing materials with current barrier devices leads to displacement of the adhesion-preventing material, rendering it ineffective. There remains a need therefore for a surgical device and method which reliably prevents injury to the bowel or viscera during closure of a surgical incision, while also aiding in reducing or preventing postoperative surgical adhesions.